NFA · Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | NFA |
|---|---|
| Device Name | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073523 | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | Medtronic, Inc. | Aug 1, 2008 | SESE |
| K073563 | MODIFICATION TO PROXIS SYSTEM | St Jude Medical | Jan 31, 2008 | SESE |
| K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Jan 19, 2007 | SESE |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Kensey Nash Corp. | Oct 20, 2006 | SESE |
| K060651 | PROXIS SYSTEM, MODEL EPS101 | St Jude Medical | Sep 13, 2006 | SESE |
| K052523 | PROXIS SYSTEM | Velocimed, Inc. | Sep 7, 2006 | SESE |
| K062201 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Aug 11, 2006 | SESE |
| K061332 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | Boston Scientific Corp | Aug 11, 2006 | SESE |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Kensey Nash Corp. | Jul 11, 2006 | SESE |
| K053195 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | Jun 23, 2006 | SESE |
| K051984 | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 | Boston Scientific Corp | Apr 10, 2006 | SESE |
| K052280 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | Boston Scientific Corp | Nov 7, 2005 | SESE |
| K051179 | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | Boston Scientific Corp | Jun 8, 2005 | SESE |
| K042040 | TRIACTIV SYSTEM | Kensey Nash Corp. | Mar 23, 2005 | SESE |
| K032884 | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH | Boston Scientific Epi | Aug 6, 2004 | SESE |
| K023691 | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | Boston Scientific Epi | Jun 4, 2003 | SESE |
| K030201 | MODIFICATION TO EXPORT ASPIRATION CATHETER | Medtronic Vascular | Mar 26, 2003 | SESE |
| K023878 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Vascular | Jan 24, 2003 | SESE |
| K013913 | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Percusurge, Inc. | Nov 15, 2002 | SESE |
| K023303 | EXPORT ASPIRATION CATHETER | Medtronic Vascular | Oct 29, 2002 | SESE |
Top Applicants
- Boston Scientific Corp — 4 clearances
- Ev3, Inc. — 3 clearances
- Kensey Nash Corp. — 3 clearances
- Medtronic Vascular — 3 clearances
- Boston Scientific Epi — 2 clearances
